Department of Cardiology, Xinqiao Hospital, Army Medical University, Chongqing, China.
Department of Cardiology, Xinqiao Hospital, Army Medical University, Chongqing, China
BMJ Open. 2024 Feb 27;14(2):e080539. doi: 10.1136/bmjopen-2023-080539.
Pulmonary vein isolation (PVI) is the cornerstone of radiofrequency (RF) ablation for atrial fibrillation (AF). However, a single ablation strategy does not always achieve the desired therapeutic effect in all patients with persistent AF, and individualised strategies are required for different clinical characteristics.
This study aimed to determine the optimal catheter ablation strategy for persistent AF by comparing the efficacy of PVI and BCXL (BC: big circles encircling pulmonary vein isolation; XL: unfixed number of lines based on the left atrial substrate). The BCXL-AF study (clinical trial no. ChiCTR2200067081) was designed as a prospective, randomised, parallel-controlled, single-blinded clinical trial. Overall, 400 patients with persistent AF were randomised in a 1:1 ratio into PVI-only and BCXL-individualised ablation groups. Patients randomised to the individualised ablation group will be further categorised into risk strata according to their clinical condition using the actual ablation method determined by the strata. Seven postoperative visits were conducted from discharge to 24 months of age. The primary observation endpoint will be the incidence of atrial tachyarrhythmia (including AF, atrial flutter and atrial tachycardia with a duration of ≥30 s) without using antiarrhythmic drugs after a blank period of 3 months following a single ablation procedure. The BCXL-AF study will assess an optimal approach for persistent AF RF ablation and evaluate the effectiveness of individualised RF ablation strategies in reducing the recurrence rate of AF.
The study protocol was reviewed, and ethical approval was obtained from the Army Medical University Human Ethics Committee (approval number: 2022-484-01). All the participants provided written informed consent. This study was conducted according to the principles of the Declaration of Helsinki and its amendments. The results of this study will be disseminated through manuscript publication and conference presentations.
ChiCTR2200067081.
肺静脉隔离（PVI）是射频（RF）消融治疗心房颤动（AF）的基石。然而，对于持续性 AF 的所有患者，单一消融策略并不总能达到理想的治疗效果，需要针对不同的临床特征制定个体化策略。
本研究旨在通过比较 PVI 和 BCXL（BC：大圆圈环绕肺静脉隔离；XL：基于左心房基质的不固定线数）的疗效，确定持续性 AF 的最佳导管消融策略。BCXL-AF 研究（临床试验编号 ChiCTR2200067081）设计为前瞻性、随机、平行对照、单盲临床试验。共有 400 例持续性 AF 患者以 1:1 的比例随机分为仅 PVI 和 BCXL 个体化消融组。随机分到个体化消融组的患者将根据其临床情况，使用由分层决定的实际消融方法，进一步分为风险分层。从出院到 24 个月龄进行 7 次术后随访。主要观察终点为单消融术后 3 个月空白期后，不使用抗心律失常药物时，房性快速性心律失常（包括 AF、心房扑动和持续时间≥30s 的房性心动过速）的发生率。BCXL-AF 研究将评估持续性 AF RF 消融的最佳方法，并评估个体化 RF 消融策略在降低 AF 复发率方面的有效性。
该研究方案经过审查，获得了陆军军医大学人体伦理委员会的批准（批准号：2022-484-01）。所有参与者均提供了书面知情同意书。本研究按照《赫尔辛基宣言》及其修正案的原则进行。该研究的结果将通过论文发表和会议报告进行传播。
ChiCTR2200067081。
